Massage therapy is one of the fastest-growing complementary and alternative medical therapies with a 36% increase in visits to massage therapists between 1990 and 1997 and an estimated annual cost of 4 to 6 billion dollars. Individuals seek-out massage therapy for an array of concerns including backaches, muscle aches, headaches, feelings of tension, anxiety, fatigue, and insomnia. Massage therapy is purported to improve circulation, decrease symptoms of anxiety, depression, and pain, as well as stimulate feelings of well being. Despite its widespread use, there has been little systematic investigation of the efficacy of massage in carefully characterized patient populations and very little is known about the interaction between pathological conditions and the mechanism of action of massage therapy. As acknowledged in the White House Commission on Complementary and Alternative Medicine Policy (2002), there is a need for research investigating the efficacy of massage therapy in traditional medical disorders as well as studies explaining the mechanism responsible for the beneficial effects of massage therapy. In response to PA-06-510, we propose investigating the efficacy of massage therapy in well-characterized patients with Generalized Anxiety Disorder (GAD), a prevalent and debilitating condition. Our working hypothesis is that massage therapy will cause a significant decrease in both objective and subjective symptoms of GAD when compared and contrasted with the light touch condition, which we have demonstrated is a placebo. The specific aims of this pilot project are to investigate: 1) the acute effects of 6 weeks of massage therapy on the symptoms of GAD; 2) whether 12 weeks of massage therapy is more effective than 5 weeks of massage therapy in decreasing symptoms of GAD; and 5) whether massage therapy increases levels of oxytocin, decreases AVP, and HPA function in subjects with GAD. The results of the study will facilitate the development of a larger acute clinical trial investigating the efficacy of massage therapy as an alternate treatment for treatment for GAD, as well as gather preliminary data about the psychobiology of a massage intervention for GAD. PUBLIC HEALTH RELEVANCE: Despite its purported health benefits and the widespread acceptance of massage therapy throughout the world, little is known about the impact of therapeutic massage on pathological conditions such as Generalized Anxiety Disorder. Research is needed to investigate the efficacy of massage therapy in the treatment of such medical conditions and to demonstrate that it is an acceptable alternative to more traditional medical and psychological therapies. The proposed study will examine the efficacy of massage therapy for the treatment of generalized anxiety. We will gather preliminary data necessary to design a larger, randomized, controlled clinical trial. The results will also provide valuable preliminary data about the effects of massage on biological parameters in subjects with GAD.